Kornimate/medical-research-clean huggingface dataset:
assessing a clinically-meaningful opioid withdrawal phenotype

Conditions: Opioid Withdrawal; Opioid Use Disorder; Opioid Craving

Summary: evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (oud) while completing a clinically-indicated medication taper.

individuals who have opioid use disorder and are interested in being tapered off of opioids will be admitted to a residential research unit for an 11-day period. all participants will be maintained on morphine for 5 days. during this period participants will complete 2 sessions (on two different days) wherein participants will receive an intramuscular injection of naloxone to precipitate a short withdrawal syndrome. participants will take a capsule prior to both sessions that will contain either placebo or the opioid withdrawal medication lofexidine. beginning on day 6 participants will be tapered off of morphine using lofexidine (as clinically indicated). at the end of the study all participants will be able to transition to buprenorphine maintenance or receive oral naltrexone and an injection of vivitrol (extended release naltrexone), consistent with standard of care practices. investigators will collect a variety of biological samples and questionnaire ratings during the study and primary outcomes will be measures of withdrawal collected throughout the study. investigators will use these data to learn more about why individuals express opioid withdrawal symptoms differently, which will help inform how to change current treatment practices to be more effective for persons with oud.

Eligibility criteria:
inclusion criteria: * 18 years - 65 year old * opioid-positive urine sample * current opioid use disorder with evidence of physical dependence * interest in undergoing opioid taper exclusion criteria: * evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention * being pregnant or breastfeeding * enrolled in methadone or buprenorphine maintenance treatment * clinically significant hypotension (\<90/60mmhg) or bradycardia (\<45bpm) * history of myocardial infarction * subjects who are positive for hepatitis b surface antigen and/or hepatitis c antibody with liver function tests outside the normal range (persons with a positive hepatitis c antibody and normal liver functions tests are not excluded from the study) * significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation
aim2: adequate selection of patients for thyroid biopsy: evaluation of a shared decision making conversation aid

Conditions: Thyroid Nodules; Thyroid Cancer

Summary: there is an epidemic of thyroid cancer that is harmful to patients and the medical system. the study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. the study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.


Eligibility criteria:
inclusion criteria: * adults \>18 years old presenting for evaluation of a thyroid nodule exclusion criteria: * patients with hyperthyroidism * patients with previous biopsy of the nodule of interest * pregnant patients * prisoners

Keywords: thyroid nodules shared decision making
photobiomodulation as a new approach for the treatment of nipple traumas

Conditions: Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

Summary: inadequate care during pregnancy and postpartum are predisposing factors for the emergence of nipple fissures. the therapeutic approach of nipple trauma care guidelines aimed at the breast and the appropriate techniques for breastfeeding. these measures, however, have a much more preventive than curative, it is not, in most cases, sufficient to power the closing of nipple trauma. the objective of this study was to evaluate the effectiveness of a phototherapy device designed specifically for the treatment of nipple trauma.


Eligibility criteria:
inclusion criteria: * women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years exclusion criteria: * previous history of cancer; use of other therapeutic modalities that might interfere with the healing of the lesions; presence of infected wounds; history of photosensitivity to light; cognitive deficits that undermine the understanding and implementation of guidelines of care for breast

Keywords: nipple trauma breast feeding phototherapy wound healing
physiotulle vs urgotul in the treatment of leg ulcer

Conditions: Leg Ulcers

Summary: the aim of this study is to assess the pain at removal of physiotulle dressing in comparison with that of urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.


Eligibility criteria:
inclusion criteria: * patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent * patient with venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) * patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue \> 70 %) * patient with venous or predominantly venous leg ulcer with low exsudate * patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm² * patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion * patient available to be monitored for at least 4 weeks * patient able to answer questionnaires and particularly to evaluate his pain exclusion criteria: * patient whose leg ulcer is locally infected (at least 3 of 5 clinical signs suggestive of infection \*)\* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema * patient requiring an analgesic treatment for the care (before dressing removal) * patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis * patient with arterial ulcer * patient with purely traumatic, infectious or neoplastic origin ulcer * patient with a diabetic neuropathy of lower limbs * patient with a known allergy to one of physiotulle or urgotul components * patient already participating in another clinical study * pregnant or breastfeeding patient patient who have been taking corticoids \> 10mg / day or cytostatics by systematic way for the three months prior to inclusion patient who have undergone surgery of saphenous trunk in the two months prior to inclusion
cognitive behavior treatment of older adults with generalized anxiety disorder in primary care

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to determine whether cognitive behavior treatment (cbt) can be delivered effectively by providers of different expertise levels in adults age 60 and older in a primary care setting.

generalized anxiety disorder (gad) is one of the most common anxiety disorders among older adults. anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. there is, however, limited evidence of the effectiveness of psychotropic medications in later life. given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts. the treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (cbt) with an anxiety clinic specialist (acs) or counselor or to usual care (uc). all participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. during the first 12 weeks, those assigned to cbt will also complete 10-12 weekly sessions, either in person or over the telephone. during the second 12 weeks, cbt patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. during the treatment phase, uc participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers. at 6 months, all participants will complete a telephone assessment. cbt patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. uc participants will be offered the option to receive brief cbt after completion of the 6 month telephone assessment. those who choose to participate in cbt will complete telephone assessments at 9 and 12 months.

Eligibility criteria:
inclusion criteria: * age 60 and older * principal or co-principal gad diagnosis * patient at participating clinic exclusion criteria: * active suicidal intent * current psychosis or bipolar disorder * substance abuse within the past month * cognitive impairment according to a mini cog screener score of 3 or lower

Keywords: generalized anxiety disorder geriatric
safety and efficacy of iontophoretic dexamethasone phosphate ophthalmic solution in non-infectious anterior uveitis

Conditions: Anterior Uveitis

Summary: the purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution egp-437 using the eyegate® ii drug delivery system (egds) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

this will be a phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. screening/baseline procedures which include bcva, slit lamp examination, fundus exam, iop by tonometry will be used to determine eligibility.

Eligibility criteria:
inclusion criteria: 1. age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an ac cell count of ≥ 11 cells 2. receive, understand, and sign a copy of the written informed consent form 3. be able to return for all study visits and willing to comply with all study-related instructions exclusion criteria:

Keywords: iontophoresis ophthalmology non-infectious anterior segment uveitis
safety evaluation of inhaled treprostinil administration following transition from inhaled ventavis in pulmonary arterial hypertension (pah) subjects

Conditions: Pulmonary Arterial Hypertension

Summary: this is a 24-month, multi-center, prospective, open-label, safety evaluation in pah subjects following transition from a stable dose of inhaled iloprost (ventavis). subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at baseline, week 6, week 12, and months 6, 12, 18 and 24 following initiation of treprostinil sodium.


Eligibility criteria:
inclusion criteria: * between 18 and 75 years of age * pah diagnosis defined by following who group i categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired \>/= 5 years), associated with collagen vascular disease, associated with hiv, associated with appetite suppressant/toxin use * baseline six-minute walk distance (6mwd) \>/= 250 meters * currently receiving ventavis and be stable at current dose for 30 days prior to baseline * if currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to baseline * previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of pah exclusion criteria: * nursing or pregnant * has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy * history of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease * use of investigational drug within 30 days of baseline

Keywords: pulmonary arterial hypertension pah treprostinil sodium inhalation ventavis iloprost
computer aided polyp detection (c3po) trial

Conditions: Colonic Polyp

Summary: computer aided detection (cade) algorithms have been developed to overcome human errors and assist endoscopists in detecting more polyps during colonoscopy. the aim of this study was to investigate the accuracy of the novel pentax discovery cade system (discovery-ai) against pre-recorded videos of colon polyps of various size, shape and pathology while using videos of normal colon segments as controls from two different institutes.

details regarding polyp size and location, morphology including paris classification, optical assessment, and bowel preparation were prospectively collected and recorded in the online redcap software. final results of polyp histology were also collected. the video library was then independently reviewed for quality assessment by 3 experienced gastroenterologists. videos that passed the initial quality assessment were then independently evaluated using the discovery-ai system. aim of the study was to evaluate overall performance of discovery-ai system for polyps of various size, morphology and pathology utilizing a prospectively developed video library.

Eligibility criteria:
inclusion criteria: * patients scheduled for a regular or screening colonoscopy at the institution as standard of care. * over 18 years of age exclusion criteria: * none if they qualify based on inclusion criteria * pregnant patients * inmate or prisoners * unable to provide informed consent
intramuscular aripiprazole in acutely agitated patients diagnosed with dementia

Conditions: Dementia; Alzheimer's Disease

Summary: the purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with dementia.


Eligibility criteria:
inclusion criteria: * acute agitation in patients with a dsm-iv diagnosis of alzheimer's, vascular or mixed dementia. exclusion criteria: * current dsm-iv axis 1 diagnosis other than alzheimer's, vascular or mixed dementia.

Keywords: acute agitation in patients diagnosed with dementia
parathyroid hormone (pth) for osteoporosis in postmenopausal women

Conditions: Postmenopausal Osteoporosis; Osteoporosis

Summary: parathyroid hormone (pth) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. however, prolonged pth treatment increases bone formation less and less over time. this study will test whether increasing the daily dose of pth sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why pth's effects on bone formation decline over time.

in women with postmenopausal osteoporosis, pth increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. still, pth is not a cure for osteoporosis in many patients because pth-stimulated bone formation declines as pth therapy continues. biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily pth therapy and then decline progressively. the study will last 18 months. blood, urine, and bone density tests will occur at screening. at the start of the study, participants will be randomly assigned to one of two pth dose regimens. patients will go to massachusetts general hospital at months 0, 3, 6, 9, 12, 15, and 18 for blood and urine collection. in addition, bone density tests by dxa will be performed at months 0, 6, 12, and 18, and by quantitative ct scans at months 0 and 18. approximately 6 weeks after any change in pth dose, each participant's blood calcium will be checked 4 to 6 hours after that day's pth injection, and her 24-hour urine calcium excretion will also be checked. participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with pth are accompanied by changes in its absorption and/or destruction and whether reduced skeletal responses to long-term treatment with pth are accompanied by parallel reductions in kidney responses to pth.

Eligibility criteria:
inclusion criteria: * three or more years after menopause * bone mineral density t-score \< or = -2.0 by dual-energy x-ray absorptiometry (dxa) of vertebrae or femoral neck, or by quantitative computerized tomography (qct) of vertebral body trabeculae exclusion criteria: * cannot walk without assistance * significant heart, kidney, liver, or malignant disease * current alcohol abuse * major psychiatric disorders * other current or past disorders known to affect bone * use of medications known to affect bone for \> 7 days in the past 12 months * use of bisphosphonates or fluoride * abnormal blood calcium, pth, 25-hydroxy vitamin d, creatinine, liver function tests, or complete blood count * elevated calcium levels in 24-hour urine collection

Keywords: osteoporosis parathyroid hormone teriparatide bone formation bone resorption
an observational study comparing delandistrogene moxeparvovec with standard of care in participants with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this is a multicenter, prospective, observational phase 4 study in the united states. the study is designed to collect both medical history and prospective data on duchenne muscular dystrophy (dmd) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with dmd receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice.


Eligibility criteria:
inclusion criteria: * has a definitive diagnosis of dmd prior to screening based on documentation of clinical findings and confirmatory genetic testing. * is currently receiving or has been prescribed to start chronic glucocorticoid therapy at the time of this observational study enrollment. a participant recruited to cohorts 1a or 2: * is at least 4 years of age at the time of enrollment. * is ambulatory per protocol specified criteria. a participant recruited to cohort 1b: - is non-ambulatory per protocol-specified criteria. for delandistrogene moxeparvovec-treated participants: - will be initiating usual care treatment with delandistrogene moxeparvovec at the time of study enrollment. for comparators: - is unexposed to dmd gene therapy at the time of study enrollment. exclusion criteria: * has any deletion of exon 8 and/or exon 9 in the dmd gene. * is currently participating in any dmd interventional study at the time of this observational study enrollment. * has a medical condition or confounding circumstances (for example, prior traumatic limitation for mobility or significant behavioral comorbidity) that, in the opinion of the investigator, might compromise: * the participant's ability to comply with the protocol-required procedures, * the participant's wellbeing or safety, and/or * the clinical interpretability of the data collected from the participant. other inclusion/exclusion criteria may apply.

Keywords: duchenne muscular dystrophy dmd observational standard of care phase 4
hypotension in the weaning from vasopressor drugs

Conditions: Septic Shock

Summary: although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. the present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.

a randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group). the selection of patients who will participate in the study will be for convenience. the randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers. the study will be carried out in the intensive care unit of a tertiary hospital in southern brazil, taking into account the clinical and surgical patients. in the intensive care unit, after randomization, patients will be identified by posters, attached to the bed. the titration of vasoactive drugs will be criterion of the assistant team.

Eligibility criteria:
inclusion criteria: * patients with septic shock, according to the definitions of sepsis - 3: septic and hypotensive patients, demanding use of vasoactive drug and lactate greater than 2 mmol/l (18 mg/dl). * patients admitted to the intensive care unit. * patients in need of associated use of norepinephrine and vasopressin. exclusion criteria: * patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care. * patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.

Keywords: vasoconstrictor agents sepsis critical care vasopressin
minimally invasive radioguided parathyroidectomy

Conditions: Primary Hyperparathyroidism

Summary: the main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). the researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).

the specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. in addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.

Eligibility criteria:
inclusion criteria: * all patients with biochemical evidence of primary hyperparathyroidism